Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/07—Endoradiosondes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
  • A61B5/0008—Temperature signals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
  • A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
  • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
  • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
  • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
  • A61B5/7235—Details of waveform analysis
  • A61B5/7246—Details of waveform analysis using correlation, e.g. template matching or determination of similarity
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
  • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Definitions

• This invention relates to a swallowable capsule comprising at least one sensor for monitoring a condition of the surroundings of the capsule.
• Miniature swallowable sensors are used for monitoring environmental conditions inside the gastrointestinal tract of animal and human beings.
• active drug delivery devices are available for enabling controlled delivery of a drug dosage at specific positions inside the gastrointestinal tract.
• sensors are included for controlling the drug delivery based on sensed conditions.
• in- vitro tests conditions are always under control, in-vivo conditions can only be guessed based on statistics. Lack of real-time in-vivo data about gastrointestinal conditions of test-subjects forces investigators to work with a very large sample base to compensate for random deviation. It is expensive, time-consuming and usually not repeatable.
• sensor capsules are sometimes swallowed at the same moment as a drug to be tested.
• the sensor capsule is then used for monitoring, e.g., the pH of the gastrointestinal tract of patients having swallowed the drug.
• the sensor capsules may provide useful information about the functioning of the tested drug.
• One of the problems of the use of sensor capsules for monitoring the effect of a drug is that the drug and the sensor capsule may not traverse the gastrointestinal tract at the same pace. Therefore, the sensed parameters may not provided information about the direct surroundings of the drug.
• this object is achieved by providing a swallowable capsule, comprising a drug reservoir for holding a pharmaceutical composite with a dissolvable drug, a wall of the drug reservoir comprising at least one opening for allowing fluid from the surroundings of the capsule to enter the drug reservoir and for allowing liberated particles of the dissolvable drug to enter the surroundings of the capsule, and at least one sensor for monitoring a condition of the surroundings of the capsule.
• the drug delivery and the sensor functionality in one capsule, it is ensured that the sensor and the drug traverse the gastrointestinal tract together.
• the sensor will continuously be able to monitor the direct environment of the drug. This makes the capsule very suitable for studying drug release, dissolution and absorption properties.
• the opening in the wall of the drug reservoir allows environmental fluid to enter the drug reservoir and to transport the drug into the capsule surroundings.
• the dissolving of the drug may take place inside the drug reservoir, resulting in dissolved drugs passing through the opening or openings in the reservoir wall.
• a gradual dissolving of the pharmaceutical composite then causes the drug to be released somewhere along the path of the capsule through the intestinal tract.
• drug particles which are gradually liberated or disintegrated from the pharmaceutical composite may be small enough to be able to pass the opening or openings in the reservoir wall without being dissolved immediately.
• the liberation of the drug particles may be initiated or caused by contact with the environmental fluid and is strongly affected by the conditions of the environmental fluid.
• the liberated drug particles may then dissolve somewhere in the intestinal tract, after having passed the reservoir wall of the capsule.
• the drug uptake is realized in the same manner as if it would have been swallowed separate from the sensor capsule. Fluid flowing into and out of the drug reservoir interacts with the pharmaceutical composite in a way similar to when it would have been swallowed separately.
• a big advantage of the swallowable capsule according to the invention is that it monitors environmental conditions of the administered drug without interfering with its in- vivo interaction and does not need the drug to be in a special form suitable for such a drug delivery mechanism.
• the drug can be placed inside the reservoir in the same form as in which it is used when administering the drug without any accompanying sensors.
• the drug reservoir can be (temporarily) opened or detached from the capsule in order to allow placement of the pharmaceutical composite in the reservoir.
• the same capsule can be used for monitoring the effects of different drugs.
• the drug does not have to be inserted into the drug reservoir during the production of the capsule.
• the drug reservoir may be loaded with the appropriate drug in a particular dosage form just before use.
• the drug reservoir comprises a meshed wall, the meshed wall comprising the at least one opening.
• the dimensions of the meshed wall may be adapted to the drug dosage form with which the capsule is intended to be used. Different meshes may be provided for use with different drug dosage forms.
• Fig. 1 schematically shows a swallowable capsule according to the invention
• Fig. 2 schematically shows an opened capsule according to the invention.
• Fig. 1 schematically shows a swallowable capsule 11 according to the invention.
• the capsule 10 comprises two modules, a drug module 18 and an electronics module 11 which are preferably separable and coupled by a coupling means 17.
• the preferred diameter of the capsule 10 is less than 20 mm, even more preferred less than 15 mm, and the preferred total length is less than 30 mm. Larger capsules 10 may be difficult to swallow and/or may have problems with traversing the gastrointestinal tract.
• the drug module 18 comprises a drug reservoir with a meshed side wall 12 which allows fluid from the environment to flow into and out of the drug reservoir.
• a meshed side wall 12 is shown, but in principle any other wall with one or more large enough openings to allow fluid flowing through may be used.
• the meshed side wall 12 may be injection molded or mad of thin metal wires, optionally a combination of both.
• Mesh opening size can be different depending on the shape, type or size of the drug dosage forms.
• the size of the opening or openings in the reservoir wall is preferably dimensioned in such a way that interaction between the drug and the environment is not hindered.
• Such a side wall is substantially open to the surroundings while physically holding the drug in place.
• the drug may, e.g., be in a tablet, capsule, granules or other usual dosage form which optionally incorporates an enteric coating, polymer matrix or other means to control drug release rate.
• the drug may comprise one or more excipients in order to make the drug available in a swallowable and stable dosage form.
• the drug reservoir may be filled with more than one tablet and/or capsule for simultaneous delivery of different drugs or to increase the dose. Interaction with the environmental fluid coming through the opening or openings in the reservoir wall may cause the drug to be dissolved. Alternatively, small drug particles are gradually liberated from the drug tablet or capsule and the environmental fluid causes the liberated drug particles to be transported out of the drug reservoir into the environment of capsule 10, where the drug will dissolve later.
• An electronics module 11 comprises at least one sensor 13, coupled to an energy source 14, e.g. a battery, for powering the sensor 13.
• the sensor may, e.g., be a pH sensor, a pressure sensor, an ion sensor, an enzyme sensor, a temperature sensor, a blood sensor or an impedance sensor.
• Sensor data may be stored in a memory 16 and/or transmitted to an external receiver (not shown) by a data transmitter 15.
• the sensor 10 is optionally capable of producing time-stamped information relating to properties of the gastrointestinal fluid nearby the capsule 10.
• the properties of the environment of the capsule 10 are determined by the physiological condition of the subject (he who has swallowed the capsule) and the effects of the drug thereon.
• Fig. 2 schematically shows an opened capsule 10 according to the invention.
• the capsule 10 consists of two separate modules 11, 18.
• the capsule 10 may be a singly body, with an opening for introducing the drug into the drug reservoir. It is also possible to already add the drug during the production of the capsule 10, but that may limit the possibilities of using the capsule 10 for different types of drugs or different drug doses.
• Each module 11, 18 comprises part of the coupling means 17 for coupling the drug module 18 to the electronics module 11.
• the coupling means 17 are preferably such that the capsule 10 can be opened and closes repeatedly. It is however also possible to provide the capsule 10 as two separate modules 11, 18 and only allow the coupling means to join those modules 11, 18 together once, after filling the drug module 18 with the appropriate drug.
• the coupling means 17 may, e.g., use a threaded coupling part for screwing the modules 11, 18 together.
• the capsule 10 shown in Fig. 2 uses a complementary hooking structure to facilitate connection of the two modules 11, 18.
• the modules 11, 18 of the capsule 10 shown are easily clicked together. A close up of this complementary hooking structure 17 in a connected state is also shown in the Figure.
• the invention also relates to a method to conduct a pharmacokinetic study on a drug in a pharmaceutical composite using a test subject, wherein a swallowable capsule 10 according to the invention is used to study the blood plasma drug concentration as a function of a condition of the surroundings of the capsule 10, the method comprising the following steps:

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Physics & Mathematics (AREA)
• Medical Informatics (AREA)
• Veterinary Medicine (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Biophysics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Pathology (AREA)
• Hematology (AREA)
• Physiology (AREA)
• Optics & Photonics (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Computer Networks & Wireless Communication (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Artificial Intelligence (AREA)
• Computer Vision & Pattern Recognition (AREA)
• Psychiatry (AREA)
• Signal Processing (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Medicinal Preparation (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Investigating Or Analysing Biological Materials (AREA)

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• 2010
  • 2010-12-14 JP JP2012543967A patent/JP2013514124A/ja active Pending
  • 2010-12-14 CN CN2010800616687A patent/CN103079453A/zh active Pending
  • 2010-12-14 WO PCT/IB2010/055790 patent/WO2011073892A1/en active Application Filing
  • 2010-12-14 EP EP10809077A patent/EP2512321A1/en not_active Withdrawn
  • 2010-12-14 US US13/516,356 patent/US20130172694A1/en not_active Abandoned

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